SAB Biotherapeutics, a US biopharma company, said that the first patient in a phase 1b clinical trial of its investigational Covid-19 therapeutic SAB-185 has been dosed.
The early-stage trial is assessing the safety and pharmacological activity of SAB-185 in Covid-19 patients.
SAB-185, which was generated from a subunit of the SARS-CoV-2 Wuhan strain, has delivered neutralization of the Munich and also the Washington strains in preclinical studies.
The investigational Covid-19 therapeutic was developed from DiversitAb Rapid Response Antibody Program in collaboration with the US government. SAB Biotherapeutics was awarded $35.6 million earlier this month from the US government towards the clinical development and manufacturing of SAB-185.
SAB Biotherapeutics had also recently launched a phase 1 trial of SAB-185 in 28 healthy volunteers with the primary goal of assessing its safety.
The phase 1b clinical trial on the other hand is a randomized, double-blind, ascending dose study of the human polyclonal antibody therapeutic, which is to be intravenously administered in 21 patients having mild or moderate Covid-19.
The primary endpoint of the phase 1b Covid-19 clinical trial is safety, while the secondary endpoints are an assessment of the course of mild and moderate disease in ambulatory patients.
According to SAB Biotherapeutics, data from the two early-stage clinical trials will be used for making an informed decision on the dosing and design of subsequent phase 2 safety and efficacy trials.
The SAB-185 phase 1b trial is expected to be held across multiple sites, which includes Sanford Health in Sioux Falls, South Dakota.
Eddie J. Sullivan – co-founder, president and CEO of SAB Biotherapeutics said: “We believe that SAB-185 has the potential to be a differentiated treatment option that provides a highly-specific match against the complexity, diversity, and mutations of SARS-CoV-2. Dosing the first patient in this study marks a major milestone for us as we continue to advance our robust COVID-19 program and represents a step forward in the fight against the ongoing global health crisis.
“The speed with which we have advanced our program reflects our deep understanding of human polyclonal antibodies, the pressing need for treatment options, and the commitment of our team to develop a novel class of immunotherapies that is designed to establish a responsive model for health crises. We look forward to continuing to progress our COVID-19 program, and developing rapid response capabilities to new and emerging diseases.”